Nctid:
NCT06224231
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>2250}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04-02", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2024-06-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-06", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-07", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Postoperative stay", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Postoperative stay is measured by: in post anesthesia care unit/intensive care unit/unknown"}], "primaryOutcomes"=>[{"measure"=>"Patient satisfaction", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Patient satisfaction with the care provided by the staff of the CC07; Measurement of satisfaction: Yes/No/Partly"}], "secondaryOutcomes"=>[{"measure"=>"Campus", "timeFrame"=>"Time in the outpatient clinic of anesthesia, an average of 1 hour", "description"=>"Campus: CCM or CVK or CBF"}, {"measure"=>"Waiting time in the premedication visit", "timeFrame"=>"Time in the outpatient clinic of anesthesia, an average of 1 hour", "description"=>"Measurement of waiting time: \\< 15 minutes, 15-30 minutes, 30-60 minutes, \\> 60 minutes"}, {"measure"=>"Friendliness of the staff during the premedication visit", "timeFrame"=>"Time in the outpatient clinic of anesthesia, an average of 1 hour", "description"=>"Measurement of friendliness: Yes/No/Partly"}, {"measure"=>"Information provided during the premedication visit by the anesthetist", "timeFrame"=>"Time in the outpatient clinic of anesthesia, an average of 1 hour", "description"=>"Measurement of Information: Yes/No/Partly"}, {"measure"=>"Response to questions during the premedication visit", "timeFrame"=>"Time in the outpatient clinic of anesthesia, an average of 1 hour", "description"=>"Response to questions is measured: Yes/No/Partly"}, {"measure"=>"Fear reduction during the premedication visit", "timeFrame"=>"Time in the outpatient clinic of anesthesia, an average of 1 hour", "description"=>"Fear reduction is measured: Yes/No/Partly"}, {"measure"=>"Information provided during the premedication visit by educational films", "timeFrame"=>"Time in the outpatient clinic of anesthesia, an average of 1 hour", "description"=>"Measurement of information by educational films: Yes/No/Partly/No film"}, {"measure"=>"Compliance with the planned start of the operation", "timeFrame"=>"Time in the operation room before start of anesthesia, an average of 30 minutes", "description"=>"Measurement of compliance with the start of the operation: Yes/No"}, {"measure"=>"Friendliness of staff", "timeFrame"=>"Time in the operation room before start of anesthesia, an average of 30 minutes", "description"=>"Measurement of friendliness: Yes/No/Partly"}, {"measure"=>"Fear", "timeFrame"=>"Time in the operation room before start of anesthesia, an average of 30 minutes", "description"=>"Fear measured: Yes, very much/Yes, but not much/No fear /Partly"}, {"measure"=>"Thirst", "timeFrame"=>"Time in the operation room before start of anesthesia, an average of 30 minutes", "description"=>"Thirst measured: Yes, very much/Yes, but not much/No thirst/Partly"}, {"measure"=>"Pain", "timeFrame"=>"Time in the operation room before start of anesthesia, an average of 30 minutes", "description"=>"Pain measured: Yes, strong pain/Yes, but not strong/No pain/Can't remember"}, {"measure"=>"Sufficient pain treatment", "timeFrame"=>"Time in the operation room before start of anesthesia, an average of 30 minutes", "description"=>"Sufficient pain treatment measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No pain/No treatment wanted/Partly"}, {"measure"=>"Shivering", "timeFrame"=>"Time in the operation room before start of anesthesia, an average of 30 minutes", "description"=>"Shivering is measured: Yes, strong/Yes, but not strong/No shivering/Partly"}, {"measure"=>"Sufficient therapy in case of shivering", "timeFrame"=>"Time in the operation room before start of anesthesia, an average of 30 minutes", "description"=>"Sufficient therapy in case of shivering is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No shivering/No treatment wanted/ Partly"}, {"measure"=>"Friendliness of staff", "timeFrame"=>"Time in the intensive care unit or post anesthesia care unit, an average of 3 days", "description"=>"Friendliness is measured: Yes/No/Partly"}, {"measure"=>"Post-operative nausea and vomiting (PONV)", "timeFrame"=>"Time in the intensive care unit or post anesthesia care unit, an average of 3 days", "description"=>"Measurement of PONV: nausea/vomiting/nausea and vomiting/neither nor"}, {"measure"=>"Sufficient therapy in case of PONV", "timeFrame"=>"Time in the intensive care unit or post anesthesia care unit, an average of 3 days", "description"=>"Sufficient therapy is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No PONV/No treatment wanted/Partly"}, {"measure"=>"Pain intensity", "timeFrame"=>"Time in the intensive care unit or post anesthesia care unit, an average of 3 days", "description"=>"Pain intensity is measured by likert scale: strong, moderate, low, none"}, {"measure"=>"Sufficient therapy in case of pain", "timeFrame"=>"Time in the intensive care unit or post anesthesia care unit, an average of 3 days", "description"=>"Sufficient therapy is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No pain/No treatment wanted/Partly"}, {"measure"=>"Shivering", "timeFrame"=>"Time in the intensive care unit or post anesthesia care unit, an average of 3 days", "description"=>"Sufficient therapy in case of shivering is measured: Yes/No/Partly"}, {"measure"=>"Sufficient therapy in case of shivering", "timeFrame"=>"Time in the intensive care unit or post anesthesia care unit, an average of 3 days", "description"=>"Sufficient therapy in case of shivering is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No shivering/No treatment wanted/Partly"}, {"measure"=>"Post-operative nausea and vomiting (PONV)", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Measurement of PONV: nausea/vomiting/nausea and vomiting/neither nor"}, {"measure"=>"Regional anaesthesia", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Measured: Yes / No"}, {"measure"=>"Satisfaction with regional anaesthesia", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Measurement of satisfaction: Yes/No/Partly"}, {"measure"=>"In case of need choosing of regional anaesthesia again", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Measurement of choosing again: Yes/No/Perhaps"}, {"measure"=>"Satisfaction of care through pain service", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Measurement of care through pain service: Yes/No/Partly"}, {"measure"=>"Recommendation of medical care (provided by the staff from CC07)", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Measurement of recommendation: Yes/No/Partly"}, {"measure"=>"Atmosphere", "timeFrame"=>"Time in the intensive care unit or post anesthesia care unit, an average of 3 days", "description"=>"Measurement of atmosphere: calm/busy/can´t remember"}, {"measure"=>"Postoperative fear", "timeFrame"=>"Time in the intensive care unit or post anesthesia care unit, an average of 3 days", "description"=>"Measurement of fear: Yes, very much/Yes, but not much/No fear"}, {"measure"=>"Postoperative pain", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Pain intensity is measured by likert scale: strong, moderate, low, none"}, {"measure"=>"Sufficient therapy in case of pain", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Sufficient therapy is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No pain/No treatment wanted/Partly"}, {"measure"=>"Postoperative patient controlled analgesia", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Measurement: Yes/No/I don´t know"}, {"measure"=>"Choosing of Patient controlled anesthesia", "timeFrame"=>"Time during hospital stay, an average of 2 weeks", "description"=>"Question: Would you choose patient controlled anesthesia again? Answer: Yes/No/Maybe"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Patient Satisfaction"]}, "descriptionModule"=>{"briefSummary"=>"One goal of the investigators of the Department of Anesthesiology and Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin is a continuous improvement in the quality of care to the patients. One focus is the freezing preoperatively during surgery, and on the follow-up study to assess the perceived waiting times in the anesthesiology outpatient clinic.\n\nThe project aims to quality assurance and quality improvement of the CharitéCentrum for Anesthesiology and Intensive Care Medicine 007, Charité - Universitätsmedizin Berlin .", "detailedDescription"=>"The primary objective of the survey is to assess the entire perioperative care with particular focus on the development of perceived waiting times in the anesthesiology outpatient clinic, re-evaluation of the preoperative freezing the preoperative thirst, pain, nausea and vomiting after surgery (PONV prophylaxis).\n\nThe survey will be repeated in a three-year interval (approximately 1000 - 2000 patients per survey) to monitor and improve the quality of the CharitéCentrum for Anesthesiology and Intensive Care Medicine 007, Charité - Universitätsmedizin Berlin from the patient point of view.\n\nIn order to achieve a meaningful data collection, a response rate of 50 percent should be achieved."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"1 year", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"All Patients who underwent a procedure in anesthesia", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* male and female patients who underwent a procedure in anesthesia and willing to take part in the Survey\n* aged \\>= 1 years\n\nExclusion Criteria:\n\n* unconscious patients,\n* refusal by patient / parents"}, "identificationModule"=>{"nctId"=>"NCT06224231", "briefTitle"=>"Patient Survey as a Tool to Quality Assurance and Quality Improvement 2024", "organization"=>{"class"=>"OTHER", "fullName"=>"Charite University, Berlin, Germany"}, "officialTitle"=>"Patient Survey 2024 and Following Years as a Tool to Quality Assurance and Quality Improvement - CharitéCentrum for Anesthesiology and Intensive Care Medicine 007, Charité - Universitätsmedizin Berlin", "orgStudyIdInfo"=>{"id"=>"QM-Patient survey 2024"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10117", "city"=>"Berlin,", "state"=>"Berlin", "status"=>"RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Claudia Spies, MD, Prof.", "role"=>"CONTACT", "email"=>"claudia.spies@charite.de", "phone"=>"+4930 450 55 11 02"}, {"name"=>"Claudia Spies, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Julia Wölfle, MD", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Raphael-Donatus Hein, MD", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin", "geoPoint"=>{"lat"=>52.52437, "lon"=>13.41053}}, {"zip"=>"12203", "city"=>"Berlin", "status"=>"RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Sascha Treskatsch, MD. Prof.", "role"=>"CONTACT", "email"=>"sascha.treskatsch@charite.de", "phone"=>"+49 30 450 55 15 22"}, {"name"=>"Sascha Treskatsch, MD, Prof.", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Patrick Wagner, MD", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin", "geoPoint"=>{"lat"=>52.52437, "lon"=>13.41053}}], "centralContacts"=>[{"name"=>"Claudia Spies, MD, Prof.", "role"=>"CONTACT", "email"=>"claudia.spies@charite.de", "phone"=>"+49 30 450 55 11 02"}], "overallOfficials"=>[{"name"=>"Claudia Spies, MD, Prof.", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Charite University, Berlin, Germany"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Charite University, Berlin, Germany", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Head of the CharitéCentrum for Anesthesiology and Intensive Care Medicine 007", "investigatorFullName"=>"Claudia Spies", "investigatorAffiliation"=>"Charite University, Berlin, Germany"}}}}
